bioProcessUK spotlight: All data great and small
Ahead of the 19th annual bioProcessUK conference (15-17 November, Edinburgh), we spoke to Simon Simpkins PhD, VP, Head of Operational Strategy at Oxford Biomedica about the company's digital future, where the foundational concept of good data management underpins all aspirations.
But how do you build that integrated vision and keep the business running at the same time?
If a system isn’t useful and usable it won’t be used (unless, of course, you proceduralise use or remove all alternatives). But in those cases, we shouldn’t be surprised when the sought-after benefits aren’t all realised. The useful and usable mantra is our obsession as we identify the systems Oxford Biomedica needs to realise our digital strategy; if we choose our systems well, everything else, including compliance, should flow neatly from it.
An obvious starting point is the digitisation of batch records. Gone would be the use of endless reams of paper, transcription and hand-writing errors would disappear, data could be captured and analysed in real-time, and reviews done by exception. However, when historically looking at these solutions, the excitement was always tempered, moderated, by one simple factor; how would an electronic system really function within a cleanroom environment?
What do I mean by that?
During the execution of a batch, the operator needs to confirm the sequential completion of each instruction, typically recording their initials and date in a paper document. An electronic equivalent of this would be to input a username and password when each step is completed – simple! But is it?
It’s not long ago since iPhone users had to tap out their PIN to unlock their phones. This was followed by using your fingerprints and now phones magically open by facial recognition. But when facemasks were introduced during Covid, many iPhone users were back to unlocking their devices with the PIN, and in winter when wearing gloves, that was a faff. So, how annoying it would be if you had to unlock your phone each time with an alphanumeric password of a minimum 8-characters including one upper case, two numbers and one special character etcetera, etcetera? For many modern IT systems, such complicated passwords are a minimum (along with two-factor authentication) to ensure our systems and businesses remain safe. The same is true of many electronic batch record systems which often take their username and password requirements from the company’s active directory.
So back to manufacturing, and in particular cleanrooms. Put in the shoes of an operator gowned in Grade C tunics, wearing multiple pairs of gloves, it’s easy to envision how the repetitive act of signing off a step with your username and complex password could rapidly become a frustration. The combination of username, password, and interface, coupled with the PPE becomes a barrier to the operator performing their job, and the system which offers so many benefits becomes time-consuming, awkward and a burden for the user. This is a faff; you can’t just take off the gloves.
However, as we’ve learnt on our digital journey, just as Apple has worked on the accessibility of their phones, so have the providers of these systems. Several batch record providers have sought out alternative methods to authenticate steps, some of which utilise wearable technologies (similar to a smartwatch). In such cases, once the wearable is activated by the operator (by fingerprint recognition and the user's pulse), steps can be signed-off by simply tapping the screen in the same way as you can pay for a coffee with a contactless card. The use of an algorithmic form of the user's biometric data assures the operator's identity, thus ensuring that the information entered is attributable to the individual.
It's these advances in technology which are helping address the fundamental issue of system useability, which is key to the success of any digital solution. If something doesn’t work for the user in a user-friendly manner, it doesn’t matter how smart your strategy is, it will stay just that, a strategy.